A Pilot Randomized Controlled Trial of an Intervention for Adults With Depression: the eMotion Study.
2018년 4월 18일 업데이트: University of Exeter
A Pilot Randomized Controlled Trial of a Web-based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression: the eMotion Study.
Physical activity has many potential mood enhancing benefits, and may be as effective as anti-depressants and psychological therapies for treating depression and low mood.
However, getting people with depression to become more active is challenging.
Behavioural Activation (BA) is an evidenced based psychotherapeutic treatment that focuses on increasing exposure to positive environmental stimuli which could provide an effective delivery mechanism for increasing physical activity for people who are more sedentary than the general population.
The purpose of this study is to examine the feasibility of delivering a theory informed online intervention combining physical activity and BA (eMotion) to people with depression, and to examine its effects on depressive symptoms and physical activity.
연구 개요
상세 설명
A randomised controlled trial (RCT) design will be used in this study. 120 participants experiencing depressive symptoms (>10 on the PHQ-8) over the age of 18 will be recruited from the community. Participants will be eligible to participate if the over 18, score over 10 on the PHQ-8 and, are able to walk unaided for at least 5 minutes and have access to the internet. Following baseline measures, participants will be randomised in a 1:1 ratio to the intervention or waiting list control arm and be followed up at 2 and 5 months. Those randomised to the intervention arm will receive eMotion which is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity. Main outcomes of interest include recruitment, retention, fidelity and acceptability. Baseline and follow up measures will also include the PHQ-8, and objective (GENEActvie accelerometers) and subjective (IPAQ) measures of physical activity. A parallel process evaluation will run alongside the RCT.
If effective, this intervention has the potential to improve depressive symptoms in a wide range of hard to reach people in the community and increase their physical activity. Further evaluation in a full scale RCT is planned pending results of this trial.
연구 유형
중재적
등록 (실제)
62
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Devon
-
Exeter, Devon, 영국, EX1 2LU
- University of Exeter
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Adults (aged ≥18 years).
- Adults with possible mild to moderately severe depression reflected by a score of between 10 and 23 (i.e. moderate to moderately severe depressive symptoms) on the Patient Health Questionnaire (PHQ-8) as has been done in previous studies looking at low mood and depressive symptoms.
- Adults living in the UK.
- Having access to the internet.
- Able to walk continuously and unaided for a minimum of 5 minutes.
- Provision of informed consent to participate.
Exclusion Criteria:
- Adults (aged <18 years).
- Adults without possible mild to moderately severe depression reflected by a score of between 10 and 23 (i.e. moderate to moderately severe depressive symptoms) on the Patient Health Questionnaire (PHQ-8) as has been done in previous studies looking at low mood and depressive symptoms.
- Adults not living in the UK.
- No access to the internet.
- Not able to walk continuously and unaided for a minimum of 5 minutes.
- Lacking capacity to give informed consent to participate.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: eMotion intervention
Subjects randomised to the intervention arm will receive eMotion for two months.
eMotion is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity.
|
eMotion is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity
|
|
간섭 없음: Waiting list control
Subjects in the waiting list control group will be given no intervention for two months; the control group will then be able to access eMotion if they wish but this will not form part of the research project
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depression
기간: Two months
|
Depression will be measured using tThe Personal Health Questionnaire (PHQ-8).
The PHQ-8 is an 8 item measure used to measure the frequency of depressive symptoms.
This is a freely available brief self-report questionnaire which assesses depressive symptoms based on the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV).
Each item is rated on a scale of 0 to 3 with a maximum score of 24.
It has been shown to have good validity, reliability, sensitivity and specificity.
It has also been shown to discriminate between levels of major and major severe depression being 10-19, and 20-23 respectively (Kroenke et al., 2009)
|
Two months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Objective Physical Activity
기간: Two months
|
Objective physical activity will be assessed using GeneACTIVE wrist worn accelerometers.
The accelerometer is a small wrist worn device that measures and records acceleration.
1 minute epochs will be used to measure movement, with higher counts per minute reflecting higher levels of physical activity as recommended in previous studies (Helgadóttir, Forsell, & Ekblom, 2015; Mailey et al., 2010).
|
Two months
|
|
Anxiety
기간: Two months
|
General Anxiety Disorder (GAD-7) is a 7 item scale which measures symptoms and severity of anxiety based on the DSM-IV criteria and included in the minimum IAPT data set (Spitzer, Kroenke, Williams, & Lowe, 2006).
|
Two months
|
|
Affective Mood State
기간: Two months
|
Ecological Momentary Assessment of Mood (EMA) will be taken using a one item 10 point scale asking the participant to rate their mood where 1 = sad and 10 = happy.
This will be taken twice per day randomly over five days during baseline data collection and at two months follow up using 'Text local', a text messaging service which allows participants to respond with a number response indicating their current mood at that point in time.
This approach is adapted from previous research (van Rijsbergen, Bockting, Berking, Koeter, & Schene, 2012).
|
Two months
|
|
Self-reported physical activity
기간: Two months
|
Self-reported physical activity will be measured using the short-form IPAQ which measures Minutes per week of moderate to vigorous physical activity will be assessed by using the International Physical Activity Questionnaire (IPAQ).
The IPAQ is a valid cross national measure of self-reported physical activity (Craig et al., 2003).
|
Two months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fidelity of receipt
기간: Two months
|
The website will be assessed by asking questions understanding, perceived understanding the key learning goals for participants in all groups.
|
Two months
|
|
Fidelity of enactment
기간: Two months
|
Fidelity of enactment will be measured by asking participants in all groups if they have carried out specific behaviour change techniques relating to physical activity, and behavioural activation along with rating confidence.
|
Two months
|
|
Participant satisfaction
기간: Two months
|
The Client Satisfaction Questionnaire - Short Form (CSQ-SF).
This is a 4 item measure which will be used to assess participant satisfaction in eMotion 2 months post randomization.
|
Two months
|
|
Participant views of intervention
기간: Two months
|
Qualitative interviews after the final intervention session, all participants who receive eMotion will be invited to participate in a semi structured interview over the phone.
The purpose of this is to further examine the acceptability of the intervention and any suggestions for improvement which can be absorbed into a next trial.
|
Two months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jeffrey D Lambert, MSc, University of Exeter
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 5월 1일
기본 완료 (실제)
2017년 4월 15일
연구 완료 (실제)
2017년 4월 15일
연구 등록 날짜
최초 제출
2016년 6월 15일
QC 기준을 충족하는 최초 제출
2017년 3월 13일
처음 게시됨 (실제)
2017년 3월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 4월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 4월 18일
마지막으로 확인됨
2018년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .